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Recruiting NCT07210671

Prospective Evaluation of the Treatment of Cancer Associated Superficial Venous

— Observational Superficial Vein Thrombosis Cancer Venous Thrombosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Superficial Vein Thrombosis, Cancer, Venous Thrombosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Superficial venous thrombosis (SVT) is very common in clinical practice. What's more, around 15- 20% of SVTs occur in the context of cancer. Today, cancer patients are excluded from therapeutic trials for DVT. There is therefore no high-level evidence-based treatment recommendation for these patients. Recent data suggest that the course of cancer-associated DVT is similar to that of cancer-associated deep vein thrombosis (DVT). However, there are currently few prospective data on the evolution of cancer-associated DVT in relation to the treatment used. Due to the absence of clear recommendations of treatment in case of SVT associated with cancer the investigators will perform a prospective observational study to evaluate the efficacy of different regiment of anticoagulant treatment ordered in clinical practice.

Primary outcome measures

  • risk (in %) of recurrence of VTE [Time frame: at 3-month follow-up]
Secondary outcome measures (12)
  • association (%) between initial treatment and the risk of SVT recurrence [Time frame: at 3 months]
  • association (%) between initial treatment and the risk of SVT recurrence [Time frame: at 6 months]
  • association (%) between initial treatment and the risk of SVT recurrence [Time frame: at 12 months]
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE) [Time frame: at 12 months]
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE) [Time frame: at 3 months]
  • Association (%) between initial treatment and the occurrence of DVT [Time frame: at 3 months]
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE) [Time frame: at 6 months]
  • Association (%) between initial treatment and the occurrence of DVT [Time frame: at 12 months]
  • Association (%) between initial treatment and the occurrence of DVT [Time frame: at 6 months]
  • association (%) between initial treatment and bleeding events [Time frame: at 6 months]
  • association (%) between initial treatment and bleeding events [Time frame: at 3 months]
  • association (%) between initial treatment and bleeding events [Time frame: at 12 months]

Eligibility criteria

Inclusion criteria

  • Patient over 18
  • Patient affiliated to a social security scheme
  • Patient who understands French
  • Patient with superficial venous thrombosis of the lower and upper limbs confirmed by a Doppler ultrasound less than one month old.
  • Patient with active cancer:
  • Cancer treatment within the last 6 months,
  • Detectable tumor disease, cancer treatment within the last 6 months, ongoing hormone therapy for cancer, palliative cancer.
  • The patient has received potentially non-curative cancer treatment (notably palliative chemotherapy).
  • Progression shows that the cancer treatment was not curative (due to recurrence or progression under treatment) (particularly in the case of recurrence after surgery)

Exclusion criteria

  • Patients under legal protection
  • Patients with concomitant pulmonary embolism
  • Patient with proximal or distal deep vein thrombosis
  • Patient treated with anticoagulant therapy for another indication
  • Patient with a contraindication to anticoagulation: Thrombocytopenia less than 30,000 elements/mm3, active bleeding or history of severe bleeding.
  • Patient opposed to participation in research

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT07210671 · PI2024_843_0121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗